Praxis Medical Insights

Est. 2024 • Clinical Guidelines Distilled

Made possible by volunteer editors from the University of Calgary & University of Alberta

Last Updated: 1/9/2026

RSV Vaccine Guidelines

Primary Vaccination Recommendations

  • Adults aged ≥75 years should receive a single dose of RSV vaccine regardless of comorbidities, due to significantly elevated rates of hospitalization, severe disease, and mortality, as recommended by the American College of Physicians 1, 2
  • Adults aged 60-74 years should receive RSV vaccination if they have risk factors for severe RSV disease, as the benefits clearly outweigh potential harms in this population, according to the American Academy of Family Physicians 1, 2
  • Adults aged 50-59 years with risk factors should receive RSVPreF3 (Arexvy), which is the only vaccine currently approved for this age group, as stated by the Centers for Disease Control and Prevention 1, 2

Risk Factors for Severe RSV Disease

  • Chronic obstructive pulmonary disease (COPD) is a risk factor for severe RSV disease, as reported by the American Thoracic Society 3, 1
  • Asthma is a risk factor for severe RSV disease, according to the American Academy of Allergy, Asthma, and Immunology 3, 1
  • Heart failure is a risk factor for severe RSV disease, as stated by the American Heart Association 3, 1
  • Coronary artery disease is a risk factor for severe RSV disease, as reported by the American College of Cardiology 3, 1
  • Diabetes mellitus is a risk factor for severe RSV disease, according to the American Diabetes Association 3, 1
  • Chronic kidney disease is a risk factor for severe RSV disease, as stated by the National Kidney Foundation 3, 1
  • Chronic liver disease is a risk factor for severe RSV disease, as reported by the American Association for the Study of Liver Diseases 3, 2
  • Immunocompromise is a risk factor for severe RSV disease, according to the Infectious Diseases Society of America 3, 2
  • Frailty is a risk factor for severe RSV disease, as stated by the American Geriatrics Society 3, 2
  • Dementia is a risk factor for severe RSV disease, as reported by the Alzheimer's Association 3
  • Severe obesity (BMI ≥40 kg/m²) is a risk factor for severe RSV disease, according to the American Medical Association 2
  • Neurologic/neuromuscular conditions affecting airway clearance are risk factors for severe RSV disease, as stated by the American Academy of Neurology 2

Available RSV Vaccines

  • Arexvy (RSVPreF3) is a recombinant RSV pre-fusion F protein adjuvanted with AS01E, approved for adults ≥50 years, as reported by the FDA 2
  • Abrysvo (RSVpreF) is a recombinant bivalent RSV-A and RSV-B pre-fusion F protein, approved for adults ≥60 years, according to the CDC 2
  • mRESVIA (mRNA-1345) is an mRNA vaccine, approved for adults ≥60 years, as stated by the WHO 2

Administration Guidelines

  • A single lifetime dose of RSV vaccine is currently recommended, with no booster doses indicated at this time, as recommended by the CDC 1, 2
  • The vaccine should preferably be administered between September and November, before or early in the RSV season, to maximize protection, according to the American Academy of Family Physicians 3, 1, 2
  • RSV vaccine can be co-administered with seasonal influenza vaccine at different injection sites, as stated by the American College of Physicians 3, 1, 2

Prioritization Strategy if Vaccine Supply is Limited

  • Adults aged ≥75 years should be prioritized for vaccination, as they are at highest risk for severe RSV disease, according to the American Geriatrics Society 3, 1
  • Adults aged ≥50 years with multiple risk factors should be prioritized for vaccination, as they are at increased risk for severe RSV disease, as reported by the CDC 3

Important Clinical Considerations

  • Patient attestation is sufficient evidence of risk factors, and extensive medical documentation should not be required to avoid barriers to vaccination, as stated by the American Medical Association 1, 2
  • Previous RSV infection does not confer long-lasting immunity and does not contraindicate vaccination, according to the Infectious Diseases Society of America 1
  • Postlicensure surveillance suggests a potential increased risk for Guillain-Barré syndrome (GBS) after protein subunit RSV vaccination, which informed updated recommendations, as reported by the CDC 2

Special Populations

  • All adult patients with inflammatory bowel disease (IBD) aged ≥60 years should receive RSV vaccine, as they have a 30% higher risk of hospitalization due to RSV compared with non-IBD controls, according to the American Gastroenterological Association 4
  • Adults with moderate or severe immune compromise should receive RSV vaccination, as stated by the Infectious Diseases Society of America 2

RSV Vaccines for Older Adults

Vaccine Characteristics and Efficacy

  • The American Thoracic Society recommends that adults aged 50-59 years with risk factors receive RSVPreF3, as it is the only approved option for this age group 5, 6
  • RSVPreF3 demonstrates 82.6% efficacy against RSV-associated lower respiratory tract disease in the first season, and 94.1% efficacy against severe RSV-related lower respiratory tract disease 5, 6
  • RSVpreF shows 88.9% efficacy against RSV-associated LRTI with ≥3 symptoms at end of season 1, and 77.8% efficacy at end of season 2 7
  • The European Respiratory Society notes that RSVPreF3 and RSVpreF are generally well tolerated with acceptable safety profiles 5, 6

Safety and Co-administration

  • The Centers for Disease Control and Prevention state that RSVPreF3 is more reactogenic than placebo, with injection-site pain and fatigue being most common 7
  • Serious adverse event rates are similar between vaccine and placebo groups for both RSVPreF3 (4.4% vs 4.3%) and RSVpreF (4.3% vs 4.1%) 7
  • Co-administration with influenza vaccines may result in numerically lower antibody titers for both RSV and influenza, though clinical significance is unknown 5, 6

RSV Vaccination Guidance for Patients Receiving Methotrexate or Hydroxychloroquine

Medication Management

  • The American College of Rheumatology (ACR) conditionally recommends continuing methotrexate when administering non‑influenza vaccines such as the RSV subunit vaccines, rather than holding the drug around the time of immunization. 8
  • Evidence supporting temporary discontinuation of methotrexate pertains mainly to influenza vaccination, where a 2‑week post‑vaccination hold has been shown to improve antibody responses; this evidence does not extend to RSV vaccines. 8
  • No published studies have evaluated whether pausing methotrexate enhances the immunogenicity of RSV vaccination, indicating a lack of data specific to this vaccine. 8
  • Hydroxychloroquine does not require dose adjustment or temporary discontinuation before or after RSV vaccination, as it is considered a mild immunosuppressant with minimal impact on vaccine response. Evidence from Autoimmunity Reviews and ACR supports this practice. [9][8]
  • The same sources describe hydroxychloroquine as unlikely to significantly impair vaccine‑induced immunity, reinforcing its safety to continue unchanged during RSV immunization. 9

Co‑administration and Safety

  • RSV subunit vaccines can be co‑administered with influenza vaccines in the same visit, provided they are given at separate injection sites, facilitating efficient seasonal immunization. 10
  • The most frequently reported adverse events after RSV vaccination are injection‑site pain, fatigue, muscle aches, and headache; these reactions are typically mild‑to‑moderate and resolve quickly. 10

REFERENCES

1

RSV Vaccination Recommendations [LINK]

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

2

RSV Vaccination Recommendations [LINK]

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025